Company: Echopixel, Inc. Date of Enforcement Report: 5/16/2025 Class II PRODUCT True 3D Viewer, Model: EP-00003 Recall Number: Z-1785-2025 REASON: With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image processing/review/analysis/communication/media interchange acquired from CT/MRI/ultrasound, and pre-operative analysis of surgical options), can result in incorrect display of image...Read More
Company: Echopixel, Inc. Date of Enforcement Report: 5/16/2025 Class II PRODUCT True 3D Viewer, Model: EP-00003 Recall Number: Z-1785-2025 REASON: With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image processing/review/analysis/communication/media interchange acquired from CT/MRI/ultrasound, and pre-operative analysis of surgical options), can result in incorrect display of image...Read More
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